FDA.reportPublic FDA data

Hawaiian Tropic

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2020-06-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:25:09

Label at a glance#

ProductHawaiian Tropic
Active ingredientAVOBENZONE, OCTOCRYLENE, OXYBENZONE
Label structure13 sections

Indications and uses

helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

• apply liberally 15 minutes before sun exposure. • reapply: • after 80 minutes of swimming or sweating, • immediately after towel drying • at least every 2 hours. Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit t...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%, Octocrylene 5.0%, Oxybenzone 3.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

do not get into eyes. If contact occurs, rinse throughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irriattion or rash develops.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Posion Control Center right away.

May stain some fabrics.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply liberally 15 minutes before sun exposure. • reapply: • after 80 minutes of swimming or sweating, • immediately after towel drying • at least every 2 hours.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially form 10 a.m.-2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses. • children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Neopentyl Glycol Diheptanpoate, Phenethyl Benzoate, Polymethylsilsesquioxane, VP/Eicosene Copolymer, Caprylyl Glycol, Dimethicone, Glycerin, Triethanolamine, Coco-Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteth-10 Phosphate, Dicetyl Phosphate, Disodium EDTA, Paraffin, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Mangifera Indica (Mango) Seed Butter, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Phenoxyethanol, Methylparaben, Propylparaben, Fragrance.

Other Information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1 800 NO UV RAY, Mon-Fri

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BONUS

35% MORE

HAWAIIAN

Tropic(r)

ISLAND

sport (r)

ULTRA LIGHT

high performance sunscreen

light tropical scent

30

BROAD SPECTRUM

SPF 30

UVA & UVB protection

non-greasy

won't cog pores

water/sweat resistant

(80 minutes)

10.8 FL. OZ. (319 mL)

63354-743-17 Front63354-743-17 Front63354-743-17 Back63354-743-17 Back

HAWAIIAN

Tropic

ISLAND

SPORT

ULTRA LIGHT

high performance sunscreen

light tropical scent

30

BROAD SPECTRUM

SPF 30

UVA & UVB protection

non-greasy

won't clog pores

water/sweat resistant

(80 minutes)

HT SPF 30 Lotion_2 OZ_FPHT SPF 30 Lotion_2 OZ_FP

HT SPF 30 Lotion_2 OZ_BPHT SPF 30 Lotion_2 OZ_BPHT SPF 30 Lotion_8 OZ_FPHT SPF 30 Lotion_8 OZ_FP

HT SPF 30 Lotion_8 OZ_BPHT SPF 30 Lotion_8 OZ_BP

HT SPF 30 Lotion_10.8 OZ_FPHT SPF 30 Lotion_10.8 OZ_FP

HT SPF 30 Lotion_10.8 OZ_BPHT SPF 30 Lotion_10.8 OZ_BP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63354-743-112023-11-30C16284748780-1d6a99b39-4061-a426-e053-dadaa90af4c27782e55a-3e8e-648f-e053-2991aa0a3925
63354-743-172023-11-30C16284748780-1d6a99b39-4061-a426-e053-dadaa90af4c27782e55a-3e8e-648f-e053-2991aa0a3925
63354-743-562023-11-30C16284748780-1d6a99b39-4061-a426-e053-dadaa90af4c27782e55a-3e8e-648f-e053-2991aa0a3925
63354-743-572023-11-30C16284748780-1d6a99b39-4061-a426-e053-dadaa90af4c27782e55a-3e8e-648f-e053-2991aa0a3925
63354-743-112022-01-28C16284748780-1d6a99b39-4061-a426-e053-dadaa90af4c27782e55a-3e8e-648f-e053-2991aa0a3925
63354-743-172022-01-28C16284748780-1d6a99b39-4061-a426-e053-dadaa90af4c27782e55a-3e8e-648f-e053-2991aa0a3925
63354-743-562022-01-28C16284748780-1d6a99b39-4061-a426-e053-dadaa90af4c27782e55a-3e8e-648f-e053-2991aa0a3925
63354-743-572022-01-28C16284748780-1d6a99b39-4061-a426-e053-dadaa90af4c27782e55a-3e8e-648f-e053-2991aa0a3925

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-74363354-743-11, 63354-743-57, 63354-743-56, 63354-743-17

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
PHENETHYL BENZOATE0C143929GKIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
XANTHAN GUMTTV12P4NEEIACT
PANTHENOLWV9CM0O67ZIACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
MANGOI629I3NR86IACT
CARICA PAPAYA WHOLES0U63B0Q51IACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
COCO GLUCOSIDEICS790225BIACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM7FLD91C86KIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
SHEA BUTTERK49155WL9YIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
ALOE VERA LEAFZY81Z83H0XIACT
PSIDIUM GUAJAVA WHOLE4J570BB45UIACT
COLOCASIA ESCULENTA ROOTH7B71Q0G0DIACT
TROLAMINE9O3K93S3TKIACT
PROPYLPARABENZ8IX2SC1OHIACT
PARAFFINI9O0E3H2ZEIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0b3e78e1-e7ce-41f9-e063-6394a90a30e37782e55a-3e8e-648f-e053-2991aa0a39252023-11-28WarningsExact identifier
spl set id: 7782e55a-3e8e-648f-e053-2991aa0a3925

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.